- Implement and coordinate a range of individual clinical site-management activities.
- Advise PIs on clinical site start-up and relevant operational and regulatory issues including resource allocation, and administrative issues.
- Provide leadership for planning, organizing, and conducting site visits or reverse site visits as appropriate to clinical trials units/clinical research sites to effectively fulfill site management responsibilities.
- Assess the level of clinical trials research competency of clinical research sites and the extent of research knowledge and technology available to achieve the desired quantity and quality results for the clinical research trials being conducted.
- Evaluate clinical trials units/clinical research sites' organizational structures and modes of operations in relationship to the achievement of the Division's goals and objectives in the areas of administration, clinical site management, and recruitment of patients.
- Provide oversight and technical direction for evaluation of site performance.
- Identify problems or issues that transcend individual units or trends that indicate the need for procedural clarification or policy development and recommends follow-up actions or policy directives to OCSO Director or Branch Chief.
- Conduct trainings at sites and Network meetings on relevant policies/regulations.
- Attend Network meetings, conference calls, ad hoc meetings and working groups.
- Support federal Program Officers by: 1) tracking and summarizing grantee compliance with training requirements, grantee progress in meeting the grant aims by reviewing progress reports, and adherence to applicable regulations; and 2) reviewing and providing input on training materials, policies and procedures.
- Participate in the creation and review of site development and site closure-related documents and checklists.
- Interface with networks, investigators, Operations Centers, to share information and collaborate on research and site-related issues.
- Prepare oral and written presentations for internal and external programmatic and scientific meetings.
- Minimum of a BS degree in a science or health related discipline.
- Progressive experience in managing clinical trials/clinical research sites and/or monitoring clinical trials, with a minimum of 3 years experience in clinical research.
- Ability to communicate effectively, orally and in writing, with non-technical and technical staff.
- Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects
-
Clinical Advisor
1 week ago
Columbus Technologies Rockville, United StatesOverview: · Must be a US Citizen or Green Card Holder · W2 with full benefit · Some travel may be required · Offer contingent on ability to successfully pass a background check and drug screen · Columbus Technologies and Services Inc. is a strategic supplier and business partner ...
-
Clinical Advisor
1 week ago
Axle Rockville, United States(ID: · **Benefits**: · - 100% Medical, Dental & Vision Coverage for Employees · - Paid Time Off (Including Holidays) · - Employee Referral Bonus · - 401K Match · - Tuition reimbursement and professional development opportunities · - Flexible Spending Accounts: · - Healthcare (FS ...
-
Clinical Advisor
1 week ago
Rays TechServ Pvt. Ltd. Bethesda, United StatesTechnical Requirements: Clinical Advisor · - Implement and coordinate a range of individual clinical site-management activities. · - Advise PIs on clinical site start-up and relevant operational and regulatory issues including resource allocation, and administrative issues. · - P ...
-
Clinical Advisor
1 week ago
RJ IT Solutions Rockville, United StatesRJIT Solutions is an information technology and bioscience company that specializes in providing innovative solutions in biomedical research and data science. We serve healthcare organizations by leveraging the expertise of our team in science, software engineering, program/proje ...
-
Clinical Advisor
4 days ago
Columbus Technologies Rockville, United StatesOverview: · Must be a US Citizen or Green Card Holder · W2 with full benefit · Some travel may be required · Offer contingent on ability to successfully pass a background check and drug screen · Columbus Technologies and Services Inc. is a strategic supplier and business par ...
-
Clinical Advisor
1 week ago
Axle Informatics Rockville, United StatesAxle Informatics · is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, ...
-
Clinical Advisor
4 days ago
Columbus Sverige Rockville, United StatesOverview · Must be a US Citizen or Green Card Holder · W2 with full benefit · Some travel may be required · Offer contingent on ability to successfully pass a background check and drug screen · Columbus Technologies and Services Inc. is a strategic supplier and business partner ...
-
Clinical Advisor
4 days ago
Axle Inc Rockville, United StatesJob Description · Job Description · (ID: · Axle Informatics · is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around t ...
-
Clinical Advisor
4 days ago
RJ IT Solutions Rockville, United StatesRJIT Solutions is an information technology and bioscience company that specializes in providing innovative solutions in biomedical research and data science. We serve healthcare organizations by leveraging the expertise of our team in science, software engineering, program/proje ...
-
Clinical Advisor
4 days ago
Axle Rockville, United StatesJob Description · Job Description(ID: · Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe ...
-
Clinical Advisor
4 days ago
Axle Rockville, United StatesJob Description · Job Description(ID: · Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe ...
-
Clinical Advisor
4 days ago
Axle Rockville, United StatesJob Description · Job Description(ID: · Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe ...
-
Clinical Advisor
4 days ago
Axle Informatics Rockville, United StatesAxle Informatics · is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, ...
-
Clinical Advisor
1 week ago
Veear Projects Inc Rockville, United StatesTechnical Requirements: Provide project management of day-to-day DAIDS TMF activities including but not limited to coordinating and leading meetings, and discussions regarding all aspects of trial master files. · Serve as the primary reviewer of TMF deliverables including but ...
-
TMF - Clinical Advisor
1 week ago
Axle Rockville, United StatesJob Description · Job Description(ID: · Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe ...
-
Clinical Advisor
2 weeks ago
CAMRIS International Bethesda, United StatesWe are seeking a Clinical Advisor to support the National Institutes of Health's (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel Advisor, Clinical, Clinical Re ...
-
Clinical Advisor
1 day ago
CAMRIS International Bethesda, United StatesWe are seeking a Clinical Advisor to support the National Institutes of Health's (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel Clinical, Advisor, Clinical Re ...
-
Clinical Advisor
2 weeks ago
CAMRIS International Bethesda, United StatesWe are seeking a Clinical Advisor to support the National Institutes of Health's (NIH), world renowned National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, MD. Our NIAID professional, technical, and scientific support personnel Clinical, Clinical Research, A ...
-
Clinical Advisor
4 days ago
Nextonic Solutions LLC Bethesda, United StatesNextonic Solutions is seeking a highly ambitious, adaptable, structured, and detail-oriented Clinical Advisor to join our vibrant team at the National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Africa and the Domestic Partners Branc ...
-
Clinical Advisor
4 days ago
Axle Bethesda, United StatesJob Description · Job DescriptionAxle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With e ...
Clinical Advisor - Rockville, United States - GAP Solutions, Inc. (GAPSI)
Description
Position Objective: Provide services as a Clinical Advisor in support of the overall functions of the Division of AIDS, Office of Clinical Site Oversite (OCSO), Asia and the Americas Branch (AAB) within the National Institute of Allergy and Infectious Diseases (NIAID).Duties and Responsibilities:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned.
GAP Solutions is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.
